To utilize the therascreen KRAS RGQ PCR Kit, as a screening test in Amgen*s Phase 3 Clinical Study Protocol 20210081, in order to identify patients with mCRC KRAS G12C mutation positive tumors to be enrolled in the drug clinical trial. Results of…
ID
Source
Brief title
Condition
- Anal and rectal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Objective:
To utilize the therascreen KRAS RGQ PCR Kit, as a screening test in Amgen*s
Phase 3 Clinical Study Protocol 20210081, in order to identify patients with
mCRC KRAS G12C mutation positive tumors to be enrolled in the drug clinical
trial. Results of the Phase 3 Amgen Study 20210081 will serve as the basis for
establishing the clinical performance of the therascreen KRAS RGQ PCR Kit as a
companion diagnostic (CDx) for the identification of patients with metastatic
colorectal cancer, who may benefit from treatment with sotorasib.
Endpoint:
To demonstrate that the therascreen KRAS RGQ PCR Kit is safe and effective to
identify patients for sotorasib treatment, as supported by the efficacy and
safety endpoints from the sotorasib clinical trial.
Secondary outcome
N/A
Background summary
N/A - See Objectives and Study Design.
Study objective
To utilize the therascreen KRAS RGQ PCR Kit, as a screening test in Amgen*s
Phase 3 Clinical Study Protocol 20210081, in order to identify patients with
mCRC KRAS G12C mutation positive tumors to be enrolled in the drug clinical
trial. Results of the Phase 3 Amgen Study 20210081 will serve as the basis for
establishing the clinical performance of the therascreen KRAS RGQ PCR Kit as a
companion diagnostic (CDx) for the identification of patients with metastatic
colorectal cancer, who may benefit from treatment with sotorasib.
Study design
The proposed medical device clinical performance study and the medicinal
clinical trial will be conducted simultaneously as a combined trial according
to MDCG 2022-10. The clinical trial 20210081 is a Randomized, Open-label,
Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI
With or Without Bevacizumab-awwb for Treatment-naïve Subjects with Metastatic
Colorectal Cancer with KRAS p.G12C Mutation (CodeBreaK 301). It is estimated
that approximately 450 patients from 31 countries will be enroled based on the
presence of tumor KRAS G12C mutation, detected using the therascreen KRAS RGQ
PCR Kit, along with other clinical trial inclusion criteria, into the Phase III
clinical trial (Protocol 20210081, Section 5.1 & 5.2). Results from the Phase 3
Amgen Study 20210081 will be used to evaluate the clinical performance of the
therascreen KRAS RGQ PCR Kit as a CDx device for identification of patients
with mCRC who may benefit from treatment with sotorasib in treatment-naïve
patients with metastatic colorectal cancer.
Intervention
Not Applicable, Intervention is the Clinical Trial. Please refer to the
Clinical Trial Protocol for details.
Study burden and risks
N/A Please see Clinical Trial Protocol
200 Citylabs 2.0, Hathersage Road 200
Manchester M13 0BH
NL
200 Citylabs 2.0, Hathersage Road 200
Manchester M13 0BH
NL
Listed location countries
Age
Inclusion criteria
Patients with pathologically documented metastatic CRC. Clinical trial 20210081
inclusion and exclusion criteria can be found in the clinical trial protocol
20210081, Section 5.1 & 5.2.
Subjects who consent to participate in the eligibility screen for Protocol
20210081 will have their tumor tissue tested for the presence of KRAS G12C
mutation under the proposed performance study.
Patients identified for inclusion in the Amgen Clinical Study (Protocol No.
20210081), may provide an archival tumor sample collected within 5 years if
this is available. A fresh tumor biopsy may be taken at baseline if appropriate
archival tissue is not available. Tissue must be fixed in 10% neutral buffered
formalin (NBF) and embedded in paraffin.
A Formalin-Fixed Paraffin-Embedded (FFPE) tissue block (preferred), or a
minimum of 4 unstained slides (5µm sections), and a copy of the de-identified
pathology report is requested for screening. FFPE sections must be mounted on a
positively charged glass slide and tested within 111 weeks of sectioning
Acceptable biopsies for tumor tissue include core needle biopsy (CNB) or
surgical resection (RES). Fine needle aspiration (FNA), brushings, cell pellets
from pleural effusion, bone biopsy and lavage samples are not
acceptable.Additional details on the sample requirements are described in
section 7 and in the therascreen KRAS RGQ PCR Kit instructions for use
(DHF-20-1839-2-DOU-002).
Exclusion criteria
Patients with pathologically documented metastatic CRC. Clinical trial 20210081
inclusion and exclusion criteria can be found in the clinical trial protocol
20210081, Section 5.1 & 5.2.
Subjects who consent to participate in the eligibility screen for Protocol
20210081 will have their tumor tissue tested for the presence of KRAS G12C
mutation under the proposed performance study.
Patients identified for inclusion in the Amgen Clinical Study (Protocol No.
20210081), may provide an archival tumor sample collected within 5 years if
this is available. A fresh tumor biopsy may be taken at baseline if appropriate
archival tissue is not available. Tissue must be fixed in 10% neutral buffered
formalin (NBF) and embedded in paraffin.
A Formalin-Fixed Paraffin-Embedded (FFPE) tissue block (preferred), or a
minimum of 4 unstained slides (5µm sections), and a copy of the de-identified
pathology report is requested for screening. FFPE sections must be mounted on a
positively charged glass slide and tested within 111 weeks of sectioning
Acceptable biopsies for tumor tissue include core needle biopsy (CNB) or
surgical resection (RES). Fine needle aspiration (FNA), brushings, cell pellets
from pleural effusion, bone biopsy and lavage samples are not
acceptable.Additional details on the sample requirements are described in
section 7 and in the therascreen KRAS RGQ PCR Kit instructions for use
(DHF-20-1839-2-DOU-002).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85867.000.24 |